The present invention relates in general to a hyperbaric apparatus and, more particularly, to a topical hyperbaric apparatus for medical treatment which is collapsible to facilitate storage and portability, as well as being disposable and washable, and adapted for use in connection with irregular localized portions of the human body upon expansion from its collapsed storage configuration.
Hyperbaric chambers are devices which create sealed environments for the application of therapeutic gases to hasten healing of lesions or wounds on a patient's body. The introduction of pressurized oxygen into such an encapsulated environment promotes healing of various types of lesions and wounds. Specifically, it has been discovered that the treatment of lesions and wounds with a hyperbaric chamber, in conjunction with various stimuli, promotes granulation, raises the capillary blood p.sup.02, elevates the Redox potential thereby suppressing and eliminating bacterial growth.
When hyperbaric chambers were first introduced they encompassed large portions of the patient's body. For instance, in Lasley, U.S. Pat. No. 4,509,513, the patient is apparently required to stand during treatment within a flexible rolled-out tubular chamber which has one open end sealed about the patient and the other open end sealed by, for example, tape after unrolling the tubular chamber about the patient's body. This requirement for standing is at times a sufficient enough reason to preclude the use of this chamber. The Lasley chamber is also constructed to encompass a large portion of the patient's body. This requires a relatively significant amount of oxygen and exposes areas of the body which do not require treatment to the negative effects of the therapeutic atmosphere, such as drying.
As time progressed, hyperbaric chambers became more sophisticated and topical hyperbaric chambers were developed. A topical hyperbaric chamber is a device which only encapsulates a small portion of the patient's body. As these devices have evolved though, it has become apparent that significant shortcomings continue to exist. These shortcomings include the failure to provide a convenient topical hyperbaric chamber which occupies minimum space for shipping and storage, a topical hyperbaric chamber which is capable of producing a hermetic seal in many applications, a topical hyperbaric chamber which is affordable, and a topical hyperbaric chamber which is washable, i.e., sterilizable, during use and ultimately disposable.
Prior to the present invention, portable hyperbaric chambers were available, but these failed to solve many of the presently addressed problems. For instance, LoPiano, U.S. Pat. No. 4,328,799, discloses a reusable, non-collapsible chamber of complex construction which treats only a small area of the patient's body and, therefore, solves the problem of unduly exposing healthy parts of the patient's body to the drying effects of the therapeutic gases. However, this chamber fails to provide adequate seals during various applications, despite the aid of an H-shaped belt secured about the patient's body and chamber. This poor sealing is significant because many of the areas of the body where such poor sealing occurs are areas which are highly susceptible to treatable lesions, such as bedsores on the buttock. Lasley, U.S. Pat. No. 4,474,571, discloses a portable topical hyperbaric chamber similar to the LoPiano chamber.
Loori, U.S. Pat. No. 4,801,291 discloses a topical hyperbaric chamber which overcomes a number of the above-identified shortcomings and disadvantages. The Loori chamber includes a polyurethane foam shell which provides a substantially closed internal chamber having an opening to be exposed to the patient's body. An adhesive sealing material is provided on the shell about the opening for adhesively sealing the shell to the patient's body about the portion to be treated. A gas impermeable liner lines the internal chamber and makes the internal chamber substantially gas impermeable. However, it is known that the liner may have the tendency to develop leaks around its seal areas resulting in lower pressure operation than preferred.
The Loori chamber due to its construction from polyurethane foam cannot be washed or cleaned during use. This is particularly a disadvantage in cases where the patient being treated is incontinent. In addition, foam material is known to have a certain degree of memory which can result in the shell pulling away from the patient's body and thereby eliminating the seal area causing loss of the therapeutic gases and decrease in treatment effect.
There is known an Oxycure device which includes a flexible internal member made of foam material with a large hole passing through it. A plastic bag surrounds the foam member without covering one side of the hole to form a quasi-cup-like structure. The Oxycure device is further provided with a composite sleeve member including a front, multi-layer panel portion having a porous, absorbent layer adapted to contact the patient and a plastic sheet layer adapted to face the foam/plastic cup-like structure, and a rear panel portion comprising a plastic sheet. The front panel portion of the sleeve member includes an opening of the same size as the hole in the foam member. The sleeve member is slid over the front and rear faces of the cup-like structure so that the opening in the front panel portion aligns with the hole opening in the cup-like structure. Finally, the Oxycure device includes a pair of hoses which pierce in an unsecured manner the plastic sheet of the cup-like structure at the corners thereof so as to communicate with the foam member, and therefore, is a leak source. One hose is for the introduction of oxygen, while the other hose includes a pressure relief valve. Because of the porous characteristics of the front panel of the outer sleeve member of the Oxycure device, the manner in which the sleeve member is arranged and the use of a non-sealable plastic bag about the foam member, a hermetic seal is not achievable about the area being treated resulting in leakage of the treatment gases.
One common significant disadvantage and shortcoming of the aforementioned hyperbaric chambers are their physical size which greatly affects storage space and shipping costs. As hyperbaric chambers are being used on a worldwide basis, it is desirable to facilitate storage and shipment of these chambers to the greatest extent possible. As these known hyperbaric chambers are relatively large in size, the cost of shipping same is often a significant portion of the overall cost of the hyperbaric chamber.
There is known from Stivala, U.S. Pat. No. 4,224,941 a collapsible hyperbaric chamber. The chamber includes a pliable adhesive-backed pad having a central opening for framing the treatment region. A flaccid bag is secured to the top surface of the pad and is adapted to receive a treatment gas under pressure. A collar is provided about the edge of the opening inside the bag so that the gas pressure acts against the pad to insure proper sealing at the opening. Although the Stivala chamber is collapsible, its construction results in a number of disadvantages. Most significantly, the pliable adhesive-backed pad is of an extensive size which will interfere with the treatment of wounds or lesions when clustered over a small area of the patient's body. Use of the Stivala chamber is impractical, if not impossible, where there are multiple wounds or lesions in a given area as they would be covered by the adhesive-backed pad which would cause further injury to the patient.
Accordingly, there remains an unmet need for an improved portable hyperbaric chamber which is capable of being effectively applied to the less easily treatable areas of the human body, which create an effective hermetic seal thereat, and which can be easily stored and shipped at a minimum expense by virtue of its collapsible construction.